Mouth NeoplasmsCytobuccaleNCT02604121
Cytological Screening for Early Diagnosis of Precancerous or Cancerous Lesions of Oral Cavity
A study testing Orcellex® Rovers brush in people with Mouth Neoplasms, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Prospective study of diagnosis validation of a cytological technique. 200 patients with oral cavity cancerous and precancerous lesions will be enrolled. A cytological sample of the lesion will be performed by transepithelial brushing ( Orcellex® Rovers brush) in cytology liquid-based technology (methode ThinPrep 2000… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Mouth Neoplasms
- What is being tested?
- Orcellex® Rovers brush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- one or several cancerous or pre-cancerous lesions of oral cavity newly diagnosed or detected during a follow-up visit
Who cannot join
- pregnant or lactating women
- patients under juridical protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Cytological Screening for Early Diagnosis of Precancerous or Cancerous Lesions of Oral Cavity by Transepithelial Brushing in Liquid-based
Prospective study of diagnosis validation of a cytological technique. 200 patients with oral cavity cancerous and precancerous lesions will be enrolled.
A cytological sample of the lesion will be performed by transepithelial brushing ( Orcellex® Rovers brush) in cytology liquid-based technology (methode ThinPrep 2000 (Hologic®)). A microscopic double blind reading will be performed. A biopsy sampling will be carried out in accordance with current strategy of screening. The brushing diagnosis quality will be compared to the biopsy which is the gold standard.
- Conditions
- Mouth Neoplasms
- Being tested
- Orcellex® Rovers brush
- Keywords
- oral cavity, cancerous and precancerous lesions
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orcellex® Rovers brushDevice
transepithelial brushing
| Study group | Role | What they receive |
|---|---|---|
| transepithelial brushing | Experimental | transepithelial brushing in liquid-based technology + biopsy Receives: Device: Orcellex® Rovers brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic validity of lesion (Bethesda system, 2001)
Diagnostic validity (specificity and sensibility, the classification of lesions is performed according Bethesda system, 2001 and the reference is the histology of biopsy of lesion
Measured: baseline
Secondary outcomes (4)
Diagnostic validity - predictive value (positive and negative)
Calculation of predictive value (positive and negative) of cytology / the reference is histology of biopsy
Measured: baseline
Feasibility of cytology
sample rate not satisfactory= hemorrhage hiding the cells of interest
Measured: Baseline
Feasibility of cytology
sample rate not satisfactory : low cellularity of the material
Measured: Baseline
Reproducibility intra and inter observers (coefficient of kappa de cohen)
reproducibility intra and inter observers of cytology interpretation (kappa de cohen)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startFeb 2013
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mouth NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laetitia COLIN-LACOSTE, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604121
- Sponsor's protocol ID
- 12 045 03
- Acronym
- Cytobuccale
- Status last verified
- Apr 2019
- First submitted
- 18 Aug 2015
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Cytological Screening for Early Diagnosis of Precancerous or Cancerous Lesions of Oral Cavity by Transepithelial Brushing in Liquid-based
- ClinicalTrials.gov ID
- NCT02604121
- Acronym / sponsor ID
- Cytobuccale / 12 045 03
- Conditions
- Mouth Neoplasms
- Keywords
- oral cavity, cancerous and precancerous lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective study of diagnosis validation of a cytological technique. 200 patients with oral cavity cancerous and precancerous lesions will be enrolled.
A cytological sample of the lesion will be performed by transepithelial brushing ( Orcellex® Rovers brush) in cytology liquid-based technology (methode ThinPrep 2000 (Hologic®)). A microscopic double blind reading will be performed. A biopsy sampling will be carried out in accordance with current strategy of screening. The brushing diagnosis quality will be compared to the biopsy which is the gold standard.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transepithelial brushing | Experimental | Device: Orcellex® Rovers brushtransepithelial brushing in liquid-based technology + biopsy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- one or several cancerous or pre-cancerous lesions of oral cavity newly diagnosed or detected during a follow-up visit
Key exclusion criteria (2 listed)
- pregnant or lactating women
- patients under juridical protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orcellex® Rovers brushtransepithelial brushing | Device | transepithelial brushing |
Primary outcome
Diagnostic validity of lesion (Bethesda system, 2001)
Time frame: baseline
Diagnostic validity (specificity and sensibility, the classification of lesions is performed according Bethesda system, 2001 and the reference is the histology of biopsy of lesion
4 secondary outcomes
Diagnostic validity - predictive value (positive and negative)
Time frame: baseline
Feasibility of cytology
Time frame: Baseline
Feasibility of cytology
Time frame: Baseline
Reproducibility intra and inter observers (coefficient of kappa de cohen)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laetitia COLIN-LACOSTE, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orcellex® Rovers brush in people with Mouth Neoplasms, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic validity of lesion (Bethesda system, 2001) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.